BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Care Touch

    Reg #: 3016774562 · FEI: 3016774562 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Whele LLC
    Registration Number
    3016774562
    FEI Number
    3016774562
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    801 Barton Springs Rd
    City
    Austin
    State
    TX
    ZIP
    78704
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131463

    Owner / Operator

    Firm Name
    Whele, LLC
    Operator Number
    10079252
    Address
    501 Boylston St, 09B133
    City
    Boston
    State
    MA
    Postal Code
    02116
    Country
    US

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Care Touch

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198